Protocols and their effects for medical device-related pressure injury prevention among critically ill patients: a systematic review

Background A pressure injury refers to localized damage to the skin and/or tissue due to prolonged pressure, and it has recently been defined to include pressure injuries related to medical devices. Medical device-related pressure injuries occur in various sites and are difficult to detect. Even if it is detected, medical devices are essential to life for critically ill patients. Thus, it is difficult to remove or change the position of the medical device; therefore, prevention is essential. This study aims to integrate the literature on medical device-related pressure injury prevention protocols among critically ill patients. Methods The literature inclusion criteria were (1) critically ill patients, (2) device-related pressure injury interventions, (3) randomized controlled trials and quasi-experimental designs, and (4) written in Korean or English. The literature search and selection were performed following the Cochrane Handbook for Systematic Reviews of Interventions with the support of the PRISMA Guidelines. Results Twelve articles were finally selected. The incidence of medical device-related pressure injury decreased from 8.1–96.7% before intervention to 0.3–53.3% after intervention, respectively. Medical device-related pressure injury prevention was effective in reducing medical device-related pressure injury incidence when applied to patients of all ages, from neonates to adults, in a variety of intensive care units. Medical device-related pressure injury prevention strategies include nurse education, assessment, documentation, and interventions (hygiene, repositioning, emergent therapy such as protective dressing or designed equipment reducing pressure) of pressure injury. Pressure injury dressings primarily included hydrocolloid foam dressings, but transparent hydrocolloid formulations also effectively reduced medical device-related pressure injury incidence rates. Conclusions In the future, it is necessary to increase the level of evidence by applying specialized medical device-related pressure injury prevention methods for different medical devices and areas of pressure injuries, and verifying their effectiveness. Trial registration The review protocol was registered (PROSPERO registration number: CRD42022346450). Supplementary Information The online version contains supplementary material available at 10.1186/s12912-024-02080-y.


Background
A pressure injury (PI) comprises localized damage to the skin and/or underlying soft tissue usually over a bony prominence as a result of prolonged pressure or pressure in combination with shear [1,2]; it has recently been defined to include PIs related to medical devices [2].PI is associated with ineffective tissue perfusion or excessive deformation of the tissue [3].Sustained external pressures above a threshold cause prolonged ischemia, and reperfusion injury, which occurs when the blood supply is restored after a period of ischemia.This is considered an additional cause of tissue damage that causes PI.Moreover, the shear and friction may be factors affecting local capillary beds, which could be contributing to tissue hypoxia [4].Tissue damage can occur not only with short periods of high pressure, but also with prolonged periods of low pressure [3].In particular, medical devicerelated pressure injuries (MDRPIs) do not occur at bony protrusions like typical PIs, but at various sites such as skin and mucous membranes where medical devices are applied, making it difficult to detect and accurately assess the depth of PIs [2].
The incidence of PI is an indicator of the quality of care and hospitals are applying practices to prevent PI; however, its incidence in intensive care units (ICUs) ranges from 21 to 35%, higher than 3 to 14% observed in general wards [5].PI often occurs in people with impaired mobility or sensation [4].Especially, critically ill patients often have uncontrollable external and internal factors that make it difficult to avoid the development of PI despite the implementation of PI preventive care [6].Previous studies have identified approximately 43 risk factors for PI in critically ill patients, which can be categorized into intrinsic factors such as patient characteristics, length of stay, comorbidities, and hypotension; medical devices such as prolonged mechanical ventilation; and vasopressor agents [7].In a previous study that examined 2,203 cardiovascular ICU patients over a three-year period, the incidence of PI in the ICU was 24.4%, with 79.5% of the cases comprising stage 2 or higher PI at initial diagnosis [8].The occurrence of PI is related to a prolonged treatment period, which increases the cost of hospitalization [9] and the incidence of mortality and complications if not treated appropriately [10].Therefore, it is urgent to establish protocols for the prevention and early detection of MDRPI as well as general PI [11].
The current MDRPI prevention protocol is based on international evidence-based PI guidelines [12], but its use in clinical practice is limited due to the wide variety of medical devices associated with MDRPI and the difficulty of easily changing their location due to the nature of medical devices [13].Therefore, a systematic review of ICU MDRPI protocols is needed to provide an empirical basis for the development of PI prevention algorithms applicable in the ICU.This study aims to integrate the literature on the protocols for medical device-related pressure injury prevention among critically ill patients of all ages.

Study design
This study was a systematic review that investigated the interventions for MDRPI prevention among critically ill patients.The review protocol was registered (PROS-PERO registration number: CRD42022346450).The literature search and selection were performed in accordance with the Cochrane Handbook for Systematic Reviews of Interventions [14] and the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA-P) checklist for systematic reviews [15].

Inclusion and exclusion criteria
The inclusion criteria are delineated using PICO-SD (Population, Intervention, Comparison, Outcome, Study Design) framework as follows: (1) P: Critically ill patients with MDRPI, (2) I: PI prevention protocol, (3) C and (4) O: Not specified during the literature search, and (5) SD: Randomized controlled trials (RCTs) and quasiexperimental designs.Furthermore, literature written in both Korean and English languages was encompassed in the study selection process.The exclusion criteria were as follows: (1) the patient already had a medical devicerelated injury prior to ICU admission, and (2) the study involved animals.
Regarding search terms, we used MeSH terms in PubMed and Cochrane Library, and Emtree terms in EMBASE.We also added related natural language and converted it into search expressions by combining Boolean operators (AND, OR, NOT) between search terms.For the high sensitivity, we searched the literature using a combination of terms corresponding to P and I without specifying the terms of C and O.
Regarding I (PI prevention protocol), MeSH terms, including "prevention and control, " "Clinical Protocols, " "Patient Care Bundles, " and "Algorithms"; and Emtree terms, including "prevention, " "clinical protocol, " "care bundle, " and "algorithm, " as well as natural languages, were selected as search terms.All studies published after 1975 were included in the initial search.The search was conducted between August 5 and August 21, 2022.After deduplication, 2,121 articles were retrieved, and the final search expression is presented in Table S1.

Screening process and data extraction
The 2,121 retrieved articles were organized in Excel and ENDNOTE, and two researchers independently reviewed the literature.In the first step, the titles and abstracts were reviewed to select articles to be included in the study.In the second step, the full texts were reviewed to select articles for inclusion in the study, and any disagreements were resolved through discussion.Twelve articles were finally selected (Fig. 1), and their authors, study titles, journal names, years, volumes (issues), ICU, patient disease, MDRPI areas, MDRPI staging tool, type of medical device causing injury, sample size (experimental and control group), type of intervention, MDRPI prevention instruments, intervention time/session/frequency, primary outcome, and secondary outcome (if applied) were noted.

Quality appraisal and synthesis of results
The revised Cochrane risk of bias tool for randomized trials (ROB 2) was used to assess RCT quality, and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) version 2.0 was used to assess non-RCT quality [14].Two authors independently assessed the full text of each article and then reached a consensus on the conclusions.The final 12 articles were then integrated through a qualitative synthesis method.

Study selection
A total of 12 articles were selected based on the inclusion criteria.According to the search strategy, 2,841 articles were retrieved, 535 from PubMed, 1,440 from EMBASE, 138 from the Cochrane Library, and 728 from CINAHL.After excluding duplicates, 2,121 articles were reviewed.Two researchers reviewed the titles and abstracts and excluded 2,075 articles based on the exclusion criteria.We reviewed the full text of 46 articles, out of which we excluded 34 articles for the following reasons: not an experimental or quasi-experimental study (25 studies), not a study on MDRPI (7 studies), and not in English or Korean (2 studies) (Fig. 1).The assessments of the risk of bias in the selected articles are presented in Table 1; Fig. 2.

Characteristics of MDRPI
Among the 12 papers, the types of medical devices and sites where PIs occurred varied.One article did not specify a medical device and included all medical devices, with others including respiratory systemrelated masks or tubes (n = 6), endo-tracheal (ETT) and nasogastric tubes (NGT) (n = 3), continuous electroencephalographic (cEEG) electrodes (n = 1), and a foley catheter-related PI in a male patient (n = 1) (Table 2).Therefore, as the site of the MDRPI, the face (nose, nostrils, lips, and cheeks) (n = 11) and medical device insertion sites (below or above stoma, under twill ties, ETT or NGT insertion site, SpO 2 contacts, and urinary meatus) were often assessed (Table 2).As for MDRPI staging tools, most of the papers used the pressure ulcer staging system checklist (PUSS) developed by the NPIAP (National Pressure Injury Advisory Panel) [29,30] (n = 5) (Table 2).Other studies used a standardized assessment tool designed by the researchers (n = 5) [31,32] and other tools (n = 2) (Table 2).

Characteristics and effects of MDRPI prevention interventions for critically ill patients
For MDRPI prevention interventions, seven articles used care bundles or guidelines that included assessment, documentation, and performance frequency for MDRPI prevention; two articles used protective dressings at the site of medical device application; two articles used specially designed equipment; and one article designed a nursing intervention that included cleaning, catheter placement, cushioning dressings, and immobilization methods such a special positioning of the device to distribute skin pressure (Table 3).The shortest interval between MDRPI assessment was 30 min [21], and in most papers, the interval was 3 to 4 h (n = 3) (Table 3).Interventions most often included an interprofessional team approach (n = 5), followed by those provided by nurses (n = 4) (Table 3).

Primary and secondary outcomes of studies in this systematic review
The primary outcome assessed in studies included in this systematic review was the change in the incidence or occurrence rate of MDRPI among critically ill patients after the application of interventions.The study found that in most cases (n = 9), MDRPI was significantly lower post-intervention compared to pre-intervention (Table 4).Specifically, this study reported reductions in MDRPI rates from 13.4 to 0.89% [18], 8.5-3.5% [19], 8.1-0.3%[20], 96.7-53.3% or 40% [21], 90-32.1% [23], 77.8-13.1% [23], 30.4-18.1% [24], 12.1-0.86%[25], 72.6-43.3%[26], 28.6-24.1% [28], and 67.3-38.6%[28] before and after intervention, respectively (Table 4).Regarding secondary outcomes, besides the incidence rate, notable findings included a decrease in abscesses and infections related to the PI from 22.2% pre-intervention to 0% post-intervention (n = 1) [19].The duration until a PI occurred was also significantly different between the intervention and control groups (n = 2) [20,21], and the median survival times of the nasal skin integrity were significantly higher in the experimental group than in the control group (n = 1) [26].Additionally, the comfort level of patients was significantly higher in the intervention group than in the control group, and the degree of tracheal tube displacement was significantly less in the intervention group than in the control group (n = 1) [25] (Table 4).

Quality assessment
The quality of RCT studies (n = 4) was assessed using ROB 2 (Fig. 2), and the risk of bias in Non-RCT studies (n = 8) was assessed using ROBINS-I (Table 1).According to the ROB 2 evaluation, the overall biases were categorized as high risk (n = 1) and some concerns (n = 3) (Fig. 2).Conversely, the overall biases using ROBINS-I were classified as critical (n = 1), serious (n = 4), and moderate (n = 3) (Table 1).

Discussion
PIs in critically ill patients adversely affect patient outcomes [33].Since 2016, when the National Pressure Injury Advisory Panel revised the PI staging system to include damage caused by medical devices [34], medical devices have been recognized as a significant risk factor for PI [30].Against this backdrop, this systematic review aimed to investigate the literature on the protocols for MDRPI prevention among critically ill patients of all ages.Fourteen studies met our inclusion criteria, only adult (n = 5), from neonate to pediatric (n = 2), not  reported or mixed age (n = 2).The majority (62.5%) in the non-randomized studies (n = 8) were assessed as serious to critical bias, and just 37.5% were classified as moderate bias.In the RCT studies (n = 4), the risk of biases were some concerns (n = 3), and high risk (n = 1).Our results highlight the need for the development of evidencebased RCT studies.
The pre-intervention MDRPI incidence varied from 8.1 to 96.7%, which includes the stage I PI (intact skin with non-blanchable redness of a localized area) [23,30]; this range was higher than that of 0.9-41.2% in a previous study of critically ill patients [35].It is believed the incidence of MDRPIs was significantly reduced in the studies using MDRPI prevention strategies, including careful assessment, accurate documentation, protective   TRPU incidence rates decreased from the baseline period (8.1%) to the intervention period (0.3%).TRPU bed days decreased from the baseline period (12.5%) to the intervention period (0.2%).

Occurrence duration time
The occurrence of pressure ulcers was significantly less in the tegaderm (53.3%) and tegasorb groups (40%) compared to the control group (96.7%).The duration time of pressure ulcer was significantly longer in the tegaderm (2628 ± 1655 min) and tegasorb groups (3272 ± 2566 min) compared to the control group (1111 ± 2169), but there was no significant difference between the experimental groups.Krzyzewski et al. (2022) [22] Standard routine care ᆞApplying protective dressings

The incidence of NIV devicerelated PI
The mean incidence rate of NIV device-related PI per 1,000 NICU patient days for each phase was as follows: 0.05 (pre-NIV guideline) 0.42 (post-NIV guideline) 0.08 (post SCB) 0.16 (sustainability) Zakaria et al. (2018) [23] Standard routine care ᆞApplying protective dressings ᆞChoosing the right size of medical equipment ᆞRepositioning

Incidence of ETT related PUs incidence of NGT related PUs
The incidence of ETT-related PUs decreased from 90-32.1% The incidence of NGT-related PUs fell from 77.8-13.1% dressings to prevent MDRPIs, selection of appropriately sized medical devices, and proper immobilization to prevent tissue damage.
The ICUs implementing prevention strategies in this study were from various departments, and the age of the population was almost equally divided between adults and pediatric patients.Even with MDRPI occurring in the same site, protective dressing options for adults and neonatal or pediatric might be different for the following reasons: Nostrils of neonatal and pediatric are so small that only thin dressings are applicable, and a dressing without adhesion poses a risk of entering into the nasal cavity [26].In this study, thin foam dressing was used in the neonatal study [22], but multiple layers of gauze were used in the adult study [25].These results cannot be generalized, but when applying the MDRPI prevention strategies, confirming whether it suits the participants' age will be crucial.MDRPI prevention strategies in most studies focused on preventing PIs caused by the specific medical devices studied, most of which were respiratory-related [17,[20][21][22][23][24][25][26].In a study that included all medical devices that cause skin, tissue, and mucosal damage without specifying a particular medical device, PIs occurred 100% of the time in nares [18].This is probably because respiratory support devices are used for the longest time among critically ill patients.It is often difficult for critically ill patients to avoid the development of PI, despite the implementation of PI prevention nursing care, due to uncontrollable external and internal factors [6].Interventions were performed to prevent PI from electroderelated injury and its secondary infections in premature infants [19].In premature infants, it may take four weeks or more for the skin barrier to form [36]; thus, care should be taken with continuous monitoring due to a potential for PI at the electrode attachment site.
This systematic review identified seven articles that employed evidence-based care bundles or guidelines for MDRPI prevention interventions [17-20, 22, 24, 27].These studies predominantly adopted a multidisciplinary approach, incorporating nurse education, PI assessment, PI documentation, and various PI interventions as part of their strategies.Through an interprofessional team approach, respiratory therapists trained nurses on how to properly release and reattach the continuous positive airway pressure/ bilevel positive airway pressure (CPAP/ BiPAP) mask using the straps, while the charge nurse periodically assessed the skin and immediately recorded any redness or breakdown of skin using a prescribed form; the wound, ostomy, and continence nurse performed pressure redistribution using thin foam [17].In another paper, the SKINCARE bundle [18] was used to help nurses assess, document, ensure hygiene, reposition, and provide emerging therapies for MDRPI prevention (e.g., protective dressings for high-risk areas and selecting the right size of device for the individual) [18,20].These evidence-based interventions appeared to be effective, as MDRPI incidence was lower post-intervention than pre-intervention in studies using evidence-based care bundles or guidelines, except one [22].As even nurses can have difficulty handling medical devices [19], and physician consent is often required to resize or reposition medical devices to fit the patient [37], a multidisciplinary approach to MDRPI prevention strategies in ICU patients would be more effective.Moreover, in the case of MDRPI in the ICU, 79.5% of the cases involved stage 2 or higher PIs at the first detection [8]; thus, early detection through routine assessment is likely to be crucial for patient prognosis.
Interventions included cleaning the surface area [18,19,24,28], choosing the right size of medical equipment [18,23], applying protective dressings [17,18,[20][21][22][23][26][27][28], repositioning [17,18,23,24,27,28], elimination of pressure and friction [24], protection against forces of pressure and friction (maintenance of stable skin temperature, optimizing nutritional status, and promotion of mobility) [24], and the designing of a new suction device [25].Dressing types primarily included hydrocolloid foam dressings [17,18,20,26], but transparent hydrocolloid formulations were also used in some cases to allow observation of the skin beneath the device [21,22].In the case of MDRPI, it is not easy to observe before removing the medical device; thus, it is believed that the appropriate use of transparent hydrocolloid dressings may be beneficial.A study comparing Tegasorb and Tegaderm found a reduction in the incidence of PIs compared to a no-dressing control group, with no significant difference between dressing types [19].These results, however, were based on facial skin lesions in adult patients [21]; thus, replication studies with different subjects and body part injuries are required.
Most of the MDRPI assessment tools in this study used the PUSS checklist developed by the NPUAP [19,20,22,23,26,29,30].However, as various MDRPIs can present with lesions at different sites, modified or investigator-standardized staging tools were more commonly used [17,18,21,24,25,27,28].The most critical factor in MDRPI prevention involves the accurate measurement of the extent of skin and underlying tissues injury.However, not only do MDRPIs develop more rapidly than non-MDRPIs [38], but it is often difficult to accurately assess the skin underneath a medical device [12]; thus, it is essential to specialize the staging tool according to the type of medical device and site of occurrence.

Limitations
Despite the significance of this study, there are a few limitations to be acknowledged.First, the MDRPIs included in this study used different medical devices, various patients, protocols, and providers.Therefore, the results cannot be generalized, and it is necessary to conduct repeated RCT studies on MDRPI protocols applicable to specific participants.Secondly, a meta-analysis is more appropriate when a set of studies investigates identical or closely related relationships and is derived from similar research designs.In the present study, we have included studies with heterogeneity in terms of study quality, subjects, outcome variables, and intervention methods.Therefore, we have opted for a qualitative synthesis method instead of conducting a meta-analysis.
Thirdly, another significant limitation lies in the absence of skin tone information for the participants in the studies.Consequently, we could not evaluate how diverse skin tones might influence MDRPI or impact the effectiveness of MDRPI prevention strategies.Finally, many studies were conducted as quality improvement projects, and the quality assessment showed that the papers were not of high quality, suggesting a need for higher quality evidence.

Conclusions
MDRPI prevention was found to be associated with a decreased incidence of MDRPI in patients of different ages in a variety of ICUs.MDRPI prevention strategies included nurse education/PI assessment/PI documentation/PI interventions (hygiene, repositioning, emergent therapy).PI dressings primarily included hydrocolloid foam dressings, but transparent hydrocolloid formulations were also effective in reducing the incidence of MDRPI.Depending on the age group, the utilization of different PI dressings may be necessary.Therefore, a specialized interprofessional team approach is needed depending on the type of medical device and site of the occurrence.Since it is difficult to detect MDRPI early, it is necessary to educate and support nurses to develop competency in MDRPI assessment and care while establishing a systematic nursing record system that can support appropriate documentation, including images, to build a better healthcare system.

Fig. 1
Fig. 1 PRISMA flow chart for the literature selection process

Table 1
Risk of bias in non-randomized studies of intervention (ROBINS-I) (N = 8) NI; no informationFig.2 Risk of bias in randomized trials (N = 4)

Table 2
General characteristics of included studies (N = 12)

Table 4
Primary and secondary outcomes of studies in this systematic review (N = 12)